Cleared Traditional

K895136 - PERMANENT AND TEMP. PACEMAKER ELECTRODE...

K895136 is the FDA 510(k) clearance for PERMANENT AND TEMP. PACEMAKER ELECTRODE... by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K895136 · Medtronic Vascular · Cardiovascular device
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Feb 1990
Decision
176d
Days
Class 3
Risk

K895136 is an FDA 510(k) clearance for the PERMANENT AND TEMP. PACEMAKER ELECTRODE & LEAD ADA. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on February 8, 1990 after a review of 176 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Vascular devices

Submission Details

510(k) Number K895136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1989
Decision Date February 08, 1990
Days to Decision 176 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 125d · This submission: 176d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DTB Permanent Pacemaker Electrode

All 364
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K895136.
MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1
K900984 · Medtronic Vascular · May 1990
FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T
K900550 · Pacesetter Systems · Apr 1990
MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN.
K896313 · Medtronic Vascular · Mar 1990
FIVE-YEAR STERILE PACKAGING SHELF LIFE
K892528 · Daig Corp. · Jan 1990
ENDOCARDIAL SCREW-IN LEAD MODEL 1020T
K895447 · Pacesetter Systems · Dec 1989
MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS
K896443 · Possis Medical, Inc. · Dec 1989